System and method for navigating a guide wire

ABSTRACT

A catheter procedure system includes a bedside system having a guide wire, a guide wire advance/retract actuator coupled to the guide wire and a guide wire rotate actuator coupled to the guide wire and a workstation coupled to the bedside system. The workstation includes a user interface, at least one display and a controller coupled to the bedside system, the user interface and the at least one display. The controller is programmed to advance the guide wire through a path using the guide wire advance/retract actuator, determine if the guide wire is in a desired path based at least on at least one image of a region of interest, rotate the guide wire using the guide wire rotate actuator if the guide wire is not in the desired path, wherein the guide wire is rotated a predetermined amount, and retract the guide wire using the guide wire advance/retract actuator. The steps of advancing the guide wire and retracting and rotating the guide wire using guide wire advance/retract actuator and the guide wire rotate actuator are repeated until the guide wire is in the desired path. The guide wire is advanced to a desired position using the guide wire advance/retract actuator.

CROSS-REFERENCE TO RELATED PATENT APPLICATION

This application claims the benefit of U.S. Provisional Application No.62/087,890 filed Dec. 5, 2014 entitled “System And Method For NavigatingA Guide Wire” and is a continuation-in-part of U.S. application Ser. No.13/444,121 filed Apr. 11, 2012 entitled “Catheter System WithPercutaneous Device Algorithm” which is a continuation of InternationalApplication No. PCT/US2010/052178, filed Oct. 11, 2010, which claims thebenefit of U.S. Provisional Application No. 61/250,739 filed Oct. 12,2009 all of which are incorporated herein by reference in theirentirety.

BACKGROUND OF THE INVENTION

The present invention relates generally to the field of catheter systemsfor performing therapeutic procedures and in particular, to a catheterprocedure system and method for navigating a guide wire.

Vascular disease, and in particular cardiovascular disease, may betreated in a variety of ways. Surgery, such as cardiac bypass surgery,is one method for treating cardiovascular disease. However, undercertain circumstances, vascular disease may be treated with a catheterbased intervention procedure, such as angioplasty. Catheter basedintervention procedures are generally considered less invasive than someother types of procedures. If a patient shows symptoms indicative ofcardiovascular disease, an image of the patient's heart may be taken toaid in the diagnosis of the patient's disease and to determine anappropriate course of treatment. For certain disease types, such asatherosclerosis, the image of the patient's heart may show a lesion thatis blocking one or more coronary arteries. Following the diagnosticprocedure, the patient may undergo a catheter based interventionprocedure. During one type of intervention procedure, a guide wire isinserted into a blood vessel in the patient's body. The guide wire isthen advanced to the desired location, most commonly in one of the heartvessels or elsewhere in the vascular system. A catheter is then slidover the guide wire and moved through the patient's arterial systemuntil the catheter reaches the site of the lesion. In some procedures,the catheter is equipped with a balloon or a stent that when deployed atthe site of a lesion allows for increased blood flow through the portionof the coronary artery that is affected by the lesion. In addition tocardiovascular disease, other diseases (e.g., hypertension, etc.) may betreated using catheterization procedures.

For manual insertion of a guide wire, the physician applies torque andaxial push force on the proximal end of a guide wire to effect tipdirection and axial advancement at the distal end. Robotic cathetersystems have been developed that may be used to aid a physician inperforming a catheterization procedure such as a percutaneous coronaryintervention (PCI). The physician uses a robotic system to preciselysteer a coronary guide wire and balloon/stent device in order to, forexample, widen an obstructed artery. In order to perform PCI, the distaltip of a guide wire must be navigated through coronary anatomy past atarget lesion. While observing the coronary anatomy using fluoroscopy,the physician manipulates the proximal end of the guide wire in order todirect the distal tip into the appropriate vessels toward the lesion andavoid advancing into side branches. Due to the limitations offluoroscopy, poor visualization, a lack of depth perception andcompliance of the anatomy and the guide wire, it can be difficult torotate the proximal end of the guide wire and precisely direct itsdistal tip to the desired location.

It would be desirable to provide a system and method for navigating aguide wire that may reduce the amount of time needed to navigate past ajunction point thereby reducing the overall procedure time.

SUMMARY OF THE INVENTION

In accordance with an embodiment, a method for navigating a guide wireduring a catheter procedure includes advancing a guide wire through apath using a catheter procedure system, determining if the guide wire isin a desired path based at least on at least one image of a region ofinterest, rotating the guide wire using the catheter procedure system ifthe guide wire is not in the desired path, wherein the guide wire isrotated a predetermined amount, retracting the guide wire using thecatheter procedure system, repeating the steps of advancing the guidewire and rotating and retracting the guide wire using the catheterprocedure system until the guide wire is in the desired path andadvancing the guide wire to a desired position using the catheterprocedure system.

In accordance with another embodiment, a method for navigating a guidewire during a catheter procedure includes receiving a set of parametersdefining a predetermined path, automatically advancing a guide wirethrough the predetermined path using a catheter procedure system,determining if the guide wire is in the predetermined path based atleast on at least one image of a region of interest, rotating the guidewire using the catheter procedure system if the guide wire is not in thepredetermined path, wherein the guide wire is rotated a predeterminedamount, retracting the guide wire using the catheter procedure system,repeating the steps of advancing the guide wire and retracting androtating the guide wire using the catheter procedure system until theguide wire is in the predetermined path and advancing the guide wire toa desired position using the catheter procedure system.

In accordance with another embodiment, a catheter procedure systemincludes a bedside system having a guide wire, a guide wireadvance/retract actuator coupled to the guide wire and a guide wirerotate actuator coupled to the guide wire and a workstation coupled tothe bedside system including a user interface, at least one display, acontroller coupled to the bedside system, the user interface and the atleast one display, the controller programmed to advance the guide wirethrough a path using the guide wire advance/retract actuator, determineif the guide wire is in a desired path based at least on at least oneimage of a region of interest, rotate the guide wire using the guidewire rotate actuator if the guide wire is not in the desired path,wherein the guide wire is rotated a predetermined amount, retract theguide wire using the guide wire advance/retract actuator, repeat thesteps of advancing the guide wire and retracting and rotating the guidewire using guide wire advance/retract actuator and the guide wire rotateactuator until the guide wire is in the desired path and advance theguide wire to a desired position using the guide wire advance/retractactuator.

In accordance with another embodiment, a catheter procedure systemincludes a bedside system having a guide wire, a guide wireadvance/retract actuator coupled to the guide wire and a guide wirerotate actuator coupled to the guide wire and a workstation coupled tothe bedside system including a user interface, at least one display, acontroller coupled to the bedside system, the user interface and the atleast one display, the controller programmed to receive a set ofparameters defining a predetermined path using the user interface,advance the guide wire through the predetermined path using the guidewire advance/retract actuator, determine if the guide wire is in thepredetermined path based at least on at least one image of a region ofinterest, rotate the guide wire using the guide wire rotate actuator ifthe guide wire is not in the predetermined path, wherein the guide wireis rotated a predetermined amount, retract the guide wire using theguide wire advance/retract actuator, repeat the steps of advancing theguide wire and simultaneously retracting and rotating the guide wireusing the guide wire advance/retract actuator and the guide wire rotateactuator until the guide wire is in the predetermined path and advancethe guide wire to a desired position using the guide wireadvance/retract actuator.

BRIEF DESCRIPTION OF THE DRAWINGS

This application will become more fully understood from the followingdetailed description, taken in conjunction with the accompanyingfigures, wherein like reference numerals refer to like elements inwhich:

FIG. 1 is a perspective view of a catheter procedure system according toan exemplary embodiment;

FIG. 2 is a block diagram of a catheter procedure system according to anexemplary embodiment;

FIG. 3 is a block diagram of a catheter procedure system depictingvarious actuating mechanisms according to an exemplary embodiment;

FIG. 4 is a block diagram of a controller for controlling a roboticcatheter system according to an exemplary embodiment;

FIG. 5 is a block diagram of a movement instruction module according toan exemplary embodiment;

FIG. 6 illustrates a method for navigating a guide wire in accordancewith an embodiment; and

FIGS. 7A-7C illustrate an exemplary navigation of a guide wire inaccordance with an embodiment.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Before turning to the figures, which illustrate the exemplaryembodiments in detail, it should be understood that the presentapplication is not limited to the details or methodology set forth inthe description or illustrated in the figures. It should also beunderstood that the terminology is for the purpose of description onlyand should not be regarded as limiting.

Referring to FIG. 1, a catheter procedure system 10 is shown. Catheterprocedure system 10 may be used to perform catheter based medicalprocedures (e.g., percutaneous intervention procedures). Percutaneousintervention procedures may include diagnostic catheterizationprocedures during which one or more catheters are used to aid in thediagnosis of a patient's disease. For example, during one embodiment ofa catheter based diagnostic procedure, a contrast media is injected intoone or more coronary arteries through a catheter and an image of thepatient's heart is taken. Percutaneous intervention procedures may alsoinclude catheter based therapeutic procedures (e.g., balloonangioplasty, stent placement, treatment of peripheral vascular disease,etc.) during which a catheter is used to treat a disease. It should benoted, however, that one skilled in the art would recognize that,certain specific percutaneous intervention devices or components (e.g.,type of guide wire, type of catheter, etc.) will be selected based onthe type of procedure that is to be performed. Catheter procedure system10 is capable of performing any number of catheter based medicalprocedures with minor adjustments to accommodate the specificpercutaneous devices to be used in the procedure. In particular, whilethe embodiments of catheter procedure system 10 described herein areexplained primarily in relation to the diagnosis and/or treatment ofcoronary disease, catheter procedure system 10 may be used to diagnoseand/or treat any type of disease or condition amenable to diagnosisand/or treatment via a catheter based procedure. For example, catheterprocedure system 10 may be used for the treatment of hypertensionutilizing a radiofrequency emitting catheter to deactivate certainnerves that enervate the kidneys to control hypertension.

Catheter procedure system 10 includes lab unit 11 and workstation 14.Catheter procedure system 10 includes a robotic catheter system, shownas bedside system 12, located within lab unit 11 adjacent patient 21.Generally, bedside system 12 may be equipped with the appropriatepercutaneous devices (e.g., guide wires, guide catheters, workingcatheters, catheter balloons, stents, diagnostic catheters, etc.) orother components (e.g., contrast media, medicine, etc.) to allow theuser to perform a catheter based medical procedure. A robotic cathetersystem, such as bedside system 12, may be any system configured to allowa user to perform a catheter-based medical procedure via a roboticsystem by operating various controls such as the controls located atworkstation 14. Bedside system 12 may include any number and/orcombination of components to provide bedside system 12 with thefunctionality described herein. Various embodiments of bedside system 12are described in detail in P.C.T. International Application No.PCT/US2009/042720, filed May 4, 2009, which is incorporated herein byreference in its entirety.

In one embodiment, bedside system 12 may be equipped to perform acatheter based diagnostic procedure. In this embodiment, bedside system12 may be equipped with one or more of a variety of catheters for thedelivery of contrast media to the coronary arteries. In one embodiment,bedside system 12 may be equipped with a first catheter shaped todeliver contrast media to the coronary arteries on the left side of theheart, a second catheter shaped to deliver contrast media to thecoronary arteries on the right side of the heart, and a third cathetershaped to deliver contrast media into the chambers of the heart.

In another embodiment, bedside system 12 may be equipped to perform acatheter based therapeutic procedure. In this embodiment, bedside system12 may be equipped with a guide catheter, a guide wire, and a workingcatheter (e.g., a balloon catheter, a stent delivery catheter, ablationcatheter, etc.). In one embodiment, bedside system 12 may equipped witha working catheter that includes a secondary lumen that is threaded overthe guide wire during a procedure. In another embodiment, bedside system12 may be equipped with an over-the-wire working catheter that includesa central lumen that is threaded over the guide wire during a procedure.In another embodiment, bedside system 12 may be equipped with anintravascular ultrasound (IVUS) catheter. In another embodiment, any ofthe percutaneous devices of bedside system 12 may be equipped withpositional sensors that indicate the position of the component withinthe body.

Bedside system 12 is in communication with workstation 14, allowingsignals generated by the user inputs and/or control system ofworkstation 14 to be transmitted to bedside system 12 to control thevarious functions of beside system 12. Bedside system 12 also mayprovide feedback signals (e.g., operating conditions, warning signals,error codes, etc.) to workstation 14. Bedside system 12 may be connectedto workstation 14 via a communication link 38 that may be a wirelessconnection, cable connectors, or any other means capable of allowingcommunication to occur between workstation 14 and beside system 12.

Workstation 14 includes a user interface 30. User interface 30 includescontrols 16. Controls 16 allow the user to control bedside system 12 toperform a catheter based medical procedure. For example, controls 16 maybe configured to cause bedside system 12 to perform various tasks usingthe various percutaneous devices with which bedside system 12 may beequipped (e.g., to advance, retract, or rotate a guide wire, advance,retract, or rotate a working catheter, advance, retract, or rotate aguide catheter, inflate or deflate a balloon located on a catheter,position and/or deploy a stent, inject contrast media into a catheter,inject medicine into a catheter, or to perform any other function thatmay be performed as part of a catheter based medical procedure, etc.).In some embodiments, one or more of the percutaneous interventiondevices may be steerable, and controls 16 may be configured to allow auser to steer one or more steerable percutaneous device. In one suchembodiment, bedside system 12 may be equipped with a steerable guidecatheter, and controls 16 may also be configured to allow the userlocated at remote workstation 14 to control the bending of the distaltip of a steerable guide catheter. Further embodiments of cathetersystem 10 including a steerable guide catheter are disclosed in P.C.T.International Application No. PCT/US2010/27666, filed Mar. 17, 2010,which is incorporated herein by reference in its entirety.

In one embodiment, controls 16 include a touch screen 18, a dedicatedguide catheter control 29, a dedicated guide wire control 23, and adedicated working catheter control 25. In this embodiment, guide wirecontrol 23 is a joystick configured to advance, retract, or rotate aguide wire, working catheter control 25 is a joystick configured toadvance, retract, or rotate a working catheter, and guide cathetercontrol 29 is a joystick configured to advance, retract, or rotate aguide catheter. In addition, touch screen 18 may display one or moreicons (such as icons 162, 164, and 166) that control movement of one ormore percutaneous devices via bedside system 12 or to receive variousinputs from the user as discussed below. Controls 16 may also include aballoon or stent control that is configured to inflate or deflate aballoon and/or a stent. Each of the controls may include one or morebuttons, joysticks, touch screens, etc., that may be desirable tocontrol the particular component to which the control is dedicated. Asdiscussed in more detail below, catheter procedure system 10 includes apercutaneous device movement algorithm module or movement instructionmodule 114 that dictates how bedside system 12 responds to a user'smanipulation of controls 16 to cause a percutaneous device to move in aparticular way.

Controls 16 may include an emergency stop button 31 and a multiplierbutton 33. When emergency stop button 31 is pushed a relay is triggeredto cut the power supply to bedside system 12. Multiplier button 33 actsto increase or decrease the speed at which the associated component ismoved in response to a manipulation of guide catheter control 29, guidewire control 23, and working catheter control 25. For example, ifoperation of guide wire control 23 advances the guide wire at a rate of1 mm/sec, pushing multiplier button 33 may cause operation of guide wirecontrol 23 to advance the guide wire at a rate of 2 mm/sec. Multiplierbutton 33 may be a toggle allowing the multiplier effect to be toggledon and off. In another embodiment, multiplier button 33 must be helddown by the user to increase the speed of a component during operationof controls 16.

User interface 30 may include a first monitor 26 and a second monitor28. First monitor 26 and second monitor 28 may be configured to displayinformation or patient specific data to the user located at workstation14. For example, first monitor 26 and second monitor 28 may beconfigured to display image data (e.g., x-ray images, MRI images, CTimages, ultrasound images, etc.), hemodynamic data (e.g., bloodpressure, heart rate, etc.), patient record information (e.g., medicalhistory, age, weight, etc.). In addition, first monitor 26 and secondmonitor 28 may be configured to display procedure specific information(e.g., duration of procedure, catheter or guide wire position, volume ofmedicine or contrast agent delivered, etc.). In one embodiment, the usermay interact with or select various icons or information displayed onmonitors 26 and 28 using a user input device or control (e.g., a mouse).Monitor 26 and monitor 28 may be configured to display informationregarding the position and/or bend of the distal tip of a steerableguide catheter. Further, monitor 26 and monitor 28 may be configured todisplay information to provide the functionalities associated with thevarious modules of controller 40 discussed below. In another embodiment,user interface 30 includes a single screen of sufficient size to displayone or more of the display components and/or touch screen componentsdiscussed herein.

Catheter procedure system 10 also includes an imaging system 32 locatedwithin lab unit 11. Imaging system 32 may be any medical imaging systemthat may be used in conjunction with a catheter based medical procedure(e.g., non-digital x-ray, digital x-ray, CT, MRI, ultrasound, etc.). Inan exemplary embodiment, imaging system 32 is a digital x-ray imagingdevice that is in communication with workstation 14. As shown in FIG. 1,imaging system 32 may include a C-arm that allows imaging system 32 topartially or completely rotate around patient 21 in order to obtainimages at different angular positions relative to patient 21 (e.g.,sagittal views, caudal views, cranio-caudal views, etc.).

Imaging system 32 is configured to take x-ray images of the appropriatearea of patient 21 during a particular procedure. For example, imagingsystem 32 may be configured to take one or more x-ray images of theheart to diagnose a heart condition. Imaging system 32 may also beconfigured to take one or more x-ray images during a catheter basedmedical procedure (e.g., real-time images) to assist the user ofworkstation 14 to properly position a guide wire, guide catheter,working catheter, stent, etc. during the procedure. The image or imagesmay be displayed on first monitor 26 and/or second monitor 28.

In addition, the user of workstation 14 may be able to control theangular position of imaging system 32 relative to the patient to obtainand display various views of the patient's heart on first monitor 26and/or second monitor 28. Displaying different views at differentportions of the procedure may aid the user of workstation 14 properlymove and position the percutaneous devices within the 3D geometry of thepatient's heart. For example, displaying the proper view during aprocedure may allow the user to view a patient's vascular system fromthe proper angle to ensure that the distal tip of a steerable guidecatheter is bent in the proper way to ensure the catheter is moved asintended. In addition, displaying different views at different portionsof a procedure may aid the user in selecting the appropriate instructionset of movement instruction module 114 discussed below. In an exemplaryembodiment, imaging system 32 may be any 3D imaging modality of thepast, present, or future, such as an x-ray based computed tomography(CT) imaging device, a magnetic resonance imaging device, a 3Dultrasound imaging device, etc. In this embodiment, the image of thepatient's heart that is displayed during a procedure may be a 3D image.In addition, controls 16 may also be configured to allow the userpositioned at workstation 14 to control various functions of imagingsystem 32 (e.g., image capture, magnification, collimation, c-armpositioning, etc.).

Referring to FIG. 2, a block diagram of catheter procedure system 10 isshown according to an exemplary embodiment. Catheter procedure system 10may include a control system, shown as controller 40. As shown in FIG.2, controller 40 may be part of workstation 14. Controller 40 is incommunication with one or more bedside systems 12, controls 16, monitors26 and 28, imaging system 32, and patient sensors 35 (e.g.,electrocardiogram (“ECG”) devices, electroencephalogram (“EEG”) devices,blood pressure monitors, temperature monitors, heart rate monitors,respiratory monitors, etc.). In addition, controller 40 may be incommunication with a hospital data management system or hospital network34, one or more additional output devices 36 (e.g., printer, disk drive,cd/dvd writer, etc.), and a hospital inventory management system 37.

Communication between the various components of catheter proceduresystem 10 may be accomplished via communication links 38. Communicationlinks 38 may be dedicated wires or wireless connections. Communicationlinks 38 may also represent communication over a network. Catheterprocedure system 10 may be connected or configured to include any othersystems and/or devices not explicitly shown. For example, catheterprocedure system 10 may include IVUS systems, image processing engines,data storage and archive systems, automatic balloon and/or stentinflation systems, contrast media and/or medicine injection systems,medicine tracking and/or logging systems, user logs, encryption systems,systems to restrict access or use of catheter procedure system 10,robotic catheter systems of the past, present, or future, etc. Furtherembodiments of catheter procedure system 10 including inflation and/orcontrast media injection systems are disclosed in P.C.T. InternationalApplication No. PCT/US2009/67540, filed Dec. 10, 2009, which isincorporated herein by reference in its entirety.

Referring to FIG. 3, a block diagram of an embodiment of catheterprocedure system 10 is shown according to an exemplary embodiment.Catheter procedure system 10 may include various actuating mechanismsthat move an associated percutaneous device in response to a user'smanipulation of controls 16. In the embodiment shown, catheter proceduresystem 10 includes a guide wire actuating mechanism 50, a workingcatheter actuating mechanism 52, and a guide catheter actuatingmechanism 54. In other embodiments, catheter procedure system 10 mayinclude an actuating mechanism for inflating an angioplasty or stentdelivery balloon and an actuating mechanism for delivering contrastagent. In the embodiment shown, guide wire actuating mechanism 50 andworking catheter actuating mechanism 52 are incorporated within cassette56 which is coupled to a base of bedside system 12. Additionalembodiments of bedside system 12 and cassette 56 are described in detailin P.C.T. International Application No. PCT/US2009/042720, filed May 4,2009, which is incorporated herein by reference in its entirety. Furtherembodiments of catheter procedure system 10 are described in detail inP.C.T. International Application No. PCT/US2010/27666, filed Mar. 17,2010, and in P.C.T. International Application No. PCT/US2009/67540,filed Dec. 10, 2009, both of which are incorporated herein by referencein their entireties.

Guide wire actuating mechanism 50 is coupled to guide wire 58 such thatguide wire actuating mechanism 50 is able to cause guide wire 58 toadvance, retract, and rotate. Working catheter actuating mechanism 52 iscoupled to working catheter 60 such that working catheter actuatingmechanism 52 is able to cause working catheter 60 to advance, retract,and rotate. Connector 62 couples guide catheter 64 to guide catheteractuating mechanism 54 such that guide catheter actuating mechanism 54is able to cause guide catheter 64 to advance, retract, and rotate. Invarious embodiments, guide wire actuating mechanism 50, working catheteractuating mechanism 52, and guide catheter actuating mechanism may eachinclude an engagement structure (e.g., one or more pairs of pinchwheels) suitable for engaging the respective percutaneous device suchthat the actuating mechanism is able to impart axial and/or rotationalmovement to the percutaneous device.

A Y-connector 66 is coupled to guide catheter actuating mechanism 54 viaconnector 68. In various embodiments, connector 68 may be a componentseparate from both Y-connector 66 and guide catheter actuating mechanism54. In other embodiments, connector 68 may be part of (e.g., integralwith) Y-connector 66 or part of actuating mechanism 54. In theembodiment shown, Y-connector 66 is also connected to cassette 56.

In one embodiment, Y-connector 66 includes a first leg, a second leg,and a third leg. The first leg of the Y-connector is connected to or incommunication with the internal lumen of guide catheter 64. The secondleg is angled away from the longitudinal axis of guide catheter 64. Thesecond leg provides a port for the injection of fluids (e.g., contrastmedia, medicine, etc.) into the lumen of guide catheter 64. The thirdleg of Y-connector 66 is coupled to a cassette 56 and receives bothguide wire 58 and working catheter 60. Thus, by this arrangement, guidewire 58 and working catheter 60 are inserted through Y-connector 66 intothe internal lumen of guide catheter 64.

Guide wire actuating mechanism 50 includes a rotate actuator 70 and anadvance/retract actuator 72. Rotate actuator 70 is configured to causerotation of guide wire 58 about its longitudinal axis. Advance/retractactuator 72 is configured to advance and/or retract guide wire 58 (i.e.,to advance and/or retract along the longitudinal axis of the guide wire)within patient 21. Working catheter actuating mechanism 52 includes arotate actuator 74 and an advance/retract actuator 76. Rotate actuator74 is configured to cause rotation of working catheter 60 about itslongitudinal axis. Advance/retract actuator 76 is configured to advanceand/or retract working catheter 60 (i.e., to advance and/or retractalong the longitudinal axis of the working catheter) within patient 21.Guide catheter actuating mechanism 54 includes a rotate actuator 78, anadvance/retract actuator 80, and a bend actuator 82. Rotate actuator 78is configured to cause rotation of guide catheter 64 about itslongitudinal axis. Advance/retract actuator 80 is configured to advanceand/or retract guide catheter 64 (i.e., to advance and/or retract alongthe longitudinal axis of the guide catheter) within patient 21. In someembodiments, guide catheter 64 may include one or more bend controlelements that allow the user to cause bending of the distal tip of guidecatheter 64. In such an embodiment, bend actuator 82 causes the distaltip of guide catheter 64 to bend in response to a user's manipulation ofcontrols 16.

As shown in the block diagram of FIG. 3, controls 16 and controller 40located at workstation 14 are communicably coupled to various portionsof bedside system 12 to allow the user and/or control system to controlmovement of guide wire 58, working catheter 60 and guide catheter 64 andany other percutaneous devices that bedside system 12 is equipped with.In the embodiment shown, controls 16 and controller 40 are coupled toguide catheter actuating mechanism 54 to allow the user to move guidecatheter 64. In addition, controls 16 and controller 40 are coupled tocassette 56 to allow the user to control guide wire 58 via guide wireactuating mechanism 50 and to control working catheter 60 via workingcatheter actuating mechanism 52. Control signals 116 generated by thecontrols and controller at workstation 14 are communicated to bedsidesystem 12 to control movement of percutaneous devices discussed herein.

Referring to FIG. 4, a block diagram of controller 40 is shown accordingto an exemplary embodiment. Controller 40 may generally be an electroniccontrol unit suitable to provide catheter procedure system 10 with thevarious functionalities described herein. For example, controller 40 maybe an embedded system, a dedicated circuit, a general purpose systemprogrammed with the functionality described herein, etc. Controller 40includes a processing circuit 90, memory 92, communication module orsubsystem 94, communication interface 96, procedure control module orsubsystem 98, simulation module or subsystem 100, assist control moduleor subsystem 102, mode selection module or subsystem 104, inventorymodule or subsystem 106, GUI module or subsystem 108, data storagemodule or subsystem 110, and record module or subsystem 112.

Processing circuit 90 may be a general purpose processor, an applicationspecific processor (ASIC), a circuit containing one or more processingcomponents, a group of distributed processing components, a group ofdistributed computers configured for processing, etc., configuredprovide the functionality of module or subsystem components 94, 98-114.Memory 92 (e.g., memory unit, memory device, storage device, etc.) maybe one or more devices for storing data and/or computer code forcompleting and/or facilitating the various processes described in thepresent disclosure. Memory 92 may include volatile memory and/ornon-volatile memory. Memory 92 may include database components, objectcode components, script components, and/or any other type of informationstructure for supporting the various activities described in the presentdisclosure.

According to an exemplary embodiment, any distributed and/or localmemory device of the past, present, or future may be utilized with thesystems and methods of this disclosure. According to an exemplaryembodiment, memory 92 is communicably connected to processing circuit 90and module components 94, 98-114 (e.g., via a circuit or any otherwired, wireless, or network connection) and includes computer code forexecuting one or more processes described herein. A single memory unitmay include a variety of individual memory devices, chips, disks, and/orother storage structures or systems.

Module or subsystem components 94, 98-114 may be computer code (e.g.,object code, program code, compiled code, script code, executable code,or any combination thereof), hardware, software, or any combinationthereof, for conducting each module's respective functions. Modulecomponents 94, 98-114 may be stored in memory 92, or in one or morelocal, distributed, and/or remote memory units configured to be incommunication with processing circuit 90 or another suitable processingsystem.

Communication interface 96 includes one or more component forcommunicably coupling controller 40 to the other components of catheterprocedure system 10 via communication links 38. Communication interface96 may include one or more jacks or other hardware for physicallycoupling communication links 38 to controller 40, an analog to digitalconverter, a digital to analog converter, signal processing circuitry,and/or other suitable components. Communication interface 96 may includehardware configured to connect controller 40 with the other componentsof catheter procedure system 10 via wireless connections. Communicationmodule 94 is configured to support the communication activities ofcontroller 40 (e.g., negotiating connections, communication via standardor proprietary protocols, etc.).

Data storage module 110 is configured to support the storage andretrieval of information by controller 40. In one embodiment, datastorage module 110 is a database for storing patient specific data,including image data. In another embodiment, data storage module 110 maybe located on hospital network 34. Data storage module 110 and/orcommunication module 94 may also be configured to import and/or exportpatient specific data from hospital network 34 for use by controller 40.

Controller 40 also includes a procedure control module 98 configured tosupport the control of bedside system 12 during a catheter based medicalprocedure. Procedure control module 98 allows the user to operatebedside system 12 by manipulating controls 16. To provide this control,procedure control module 98 is in communication with a percutaneousdevice movement algorithm or movement instruction module 114. Movementinstruction module 114 includes one or more movement algorithms orinstruction sets (e.g., a library of instruction sets) that dictate howbedside system 12 operates in response to a user's manipulation ofcontrols 16 to produce movement of one or more of the percutaneousdevices (e.g., guide wire, working catheter, guide catheter, etc.) thatbedside system 12 is equipped with. In various embodiments, procedurecontrol module 98 is configured to generate one or more control signals116 based upon the user's manipulation of controls 16 and based upon oneor more active set of movement instructions provided by movementinstruction module 114. Control signals generated by procedure controlmodule 98 are communicated from controller 40 to the appropriateactuator or actuators of bedside system 12. The control signals controlthe appropriate actuators to cause movement of a percutaneous device inaccordance with the manipulation of controls 16 by the user and with theactive instruction set of movement instruction module 114. In thismanner, movement of the percutaneous device may be controlled fromworkstation 14. Procedure control module 98 may also cause dataappropriate for a particular procedure to be displayed on monitors 26and 28. Procedure control module 98 may also cause various icons (e.g.,icons 162, 164, 166, etc.) to be displayed on touch screen 18 that theuser may interact with to control the use of bedside system 12.

Referring to FIG. 5, movement instruction module 114 is depictedaccording to an exemplary embodiment. In one embodiment, movementinstruction module 114 is configured to allow the user to specificallycontrol each movement of a percutaneous device via bedside system 12. Inthis embodiment, movement instruction module 114 includes a user controlinstruction set 180 that includes device movement instructions to causebedside system 12 to move (e.g., advance, retract, rotate, etc.) thepercutaneous device in a predefined, set manner (e.g., at a set rate, ina set direction, etc.) in response to a particular input received bycontrols 16.

For example, user control instruction set 180 of movement instructionmodule 114 may be configured such that when guide wire control 23 isactuated, bedside system 12 causes the guide wire to advance, retract orrotate at a set rate. Thus, in this embodiment, movement instructionmodule 114 is configured to allow the user to control the rate anddirection of movement of a percutaneous device based on the user'sinteraction with controls 16. Thus, for certain procedures, the user mayselect or activate user control instruction set 180 when the userdesires to directly control every movement of the percutaneous device bymanipulating controls 16.

In one specific embodiment, the movement rate of a percutaneous devicecaused by bedside system 12 is proportional to the amount ofdisplacement of the control. For example, where controls 23, 25 and 29are joystick controls, user control instruction set 180 may beconfigured such that the movement rate of a percutaneous device causedby bedside system 12 is proportional to the degree of displacement ofthe joystick from the resting position. Further, in this embodiment, thedirection of movement (e.g., advancement or retraction) of thepercutaneous device caused by bedside system 12 is based on thedirection of displacement of the joystick from the resting position.

As discussed above, controls 16 may include a multiplier button 33.Movement instruction module 114 may include a first set of instructionsthat is active or operative when multiplier button 33 is not activatedand a second set of instructions that is operative when multiplierbutton 33 is activated. In this embodiment, the second set ofinstructions is configured to cause a percutaneous device to be movedfaster by bedside system 12 than it would be moved under the control ofthe first set of instructions. Thus, when the user presses multiplierbutton 33, the second set of instructions of movement instruction module114 is activated causing an increase in the rate of movement of apercutaneous device that results from a particular operation of controls16. For example, if the first set of instructions of movementinstruction module 114 dictates a 1 mm per second rate of advancement ofthe working catheter when control 16 is fully actuated (e.g., fulldisplacement of a joystick control), then the second set of instructionsof movement instruction module 114 may cause a 2 mm per second rate ofadvancement of the working catheter when control 16 is fully actuated.

In various embodiments, movement instruction module 114 may includevarious sets of instructions to facilitate the performance of certainmovements of percutaneous devices via bedside system 12 without the userhaving to manually manipulate controls 16 in a series of complicatedmovements to generate a particular type of movement by the percutaneousdevice. In these embodiments, a user may select or activate a particularmovement instruction set that defines a movement profile, and whencontrols 16 are manipulated by the user, the percutaneous device ismoved in accordance with the movement profile. Thus, movementinstruction module 114 may allow a particular movement of a percutaneousdevice associated with the activated instruction set to be performedconsistently in each procedure. The movement profile needed to perform aparticular procedure may depend on factors such as, the type ofcondition being treated (e.g., a chronic total occlusion (CTO), partialocclusion, etc.), the location of the condition being treated (e.g.,coronary arteries, peripheral arteries, etc.), the geometry of the areabeing treated, the particular type (e.g., make, model, size, etc.) ofpercutaneous device being used, etc.

In one embodiment, movement instruction module 114 may include an axialstep movement profile instruction set 182 that is configured to causebedside system 12 to move a percutaneous device in series of smallaxially steps or pulses when a user operates controls 16 to causeadvancement of the percutaneous device. In such an embodiment, axialstep movement profile instruction set 182 of movement instruction module114 may specify a step distance (i.e., a distance parameter of the step,e.g., 0.2 mm, 0.4 mm, 0.8 mm, 1 mm, 1.5 mm, 2 mm, etc.), a step duration(i.e., the length of time it takes the device to move the step distance,e.g., 0.05 sec, 0.1 sec, 0.3 sec, 0.5, sec, 1 sec, etc.), and a restduration (i.e., the length of time between steps, e.g., 0.05 sec, 0.1sec, 0.3 sec, 0.5, sec, 1 sec, etc.). Such pulsed movement may be usedto allow a percutaneous device to traverse a CTO. In this embodiment,advancement of the percutaneous device along its longitudinal axisoccurs in a series of pulsed axial steps defined by the step distance,step duration, and rest duration.

In another embodiment, axial step movement profile instruction set 182of movement instruction module 114 may include a movement profile thatis configured to cause bedside system 12 to intersperse one or moreretract pulses (i.e., pulses the move the device in a direction oppositeof the direction of advancement) with the axial advance pulses when auser operates controls 16 to cause net advancement of a percutaneousdevice. In one embodiment, movement instruction module 114 may beconfigured to cause bedside system 12 to move a percutaneous device in aset of forward pulses that is followed by one or more retract pulses,which is then followed by a second set of forward pulses, and so on,while the user operates controls 16 to cause advancement of thepercutaneous device. To ensure net forward progress utilizing such amovement profile, the instruction set ensures that the distance traveledduring each set of forward pulses is greater than the distance traveledduring the retract pulses. The retract pulse may allow the percutaneousdevice to disengage from a structure (e.g., lesion, vessel wall, etc.)prior to further advancement. In various embodiments, movementinstruction module 114 may be configured to cause pulsed movement of anypercutaneous device with which bedside system 12 is equipped, includingthe guide wire, working catheter, and guide catheter.

In another embodiment, movement instruction module 114 may include anautomatic rotation movement profile instruction set 184 that isconfigured to cause bedside system 12 to rotate the percutaneous deviceat a set rate as the percutaneous device is advanced and/or retracted inresponse to the user's operation of controls 16 to causeadvancement/retraction of a percutaneous device. In such an embodiment,automatic rotation movement profile instruction set 184 of movementinstruction module 114 may specify an amount of rotation experienced bythe percutaneous device as the percutaneous device is advanced orretracted (i.e., a rotation rate). The rotation rate may be specified interms of degrees of rotation per unit of axial distance traveled (e.g.,360 degrees of rotation for each 2 mm traveled, etc.) or may bespecified in terms of degrees of rotation per unit of time of axialtravel (e.g., 360 degrees of rotation for each 5 seconds of axialtravel). This embodiment allows the user to perform a drilling orcorkscrew action with the percutaneous device without having to manuallyoperate controls 16 to cause both axial movement and rotation. Invarious embodiments, movement instruction module 114 may includeinstructions to cause such movement of any device with which bedsidesystem 12 is equipped, including the guide wire, working catheter, andguide catheter.

In various embodiments, controller 40 is configured to allow a user toset or select one more of the parameters associated with a particularmovement profile. For example, a user may input or select the desiredstep distance, step duration, rest duration, rotation rate, etc., forthe movement profiles discussed above. In these embodiments, controls 16may include at least one user input device or a control (e.g., touchscreen icons 162, 164, 166, keyboard, etc.) that allows the user toinput the parameters associated with a movement profile.

In one embodiment, one or more user input devices of controls 16 may bea dedicated user input device that is associated with one of themovement instruction sets of movement instruction module 114 such thatoperation of the associated user input device itself causes bedsidesystem 12 to move the percutaneous device in accordance with themovement profile. In one embodiment, procedure control module 98 may beconfigured to display one or more icons (e.g., icons 162, 164, 166,etc.) on touch screen 18 that is associated with a set of movementinstructions (e.g., profiles 182 and 184). When the user operates ortouches one of the touch screen icons associated with a movementinstruction set, bedside system 12 is controlled to move a percutaneousdevice in accordance with the instruction set associated with the touchscreen icon. In one embodiment, certain user input devices of controls16 (e.g., one or more joysticks) may allow for total or specific controlof movement of the percutaneous device by the user, and manipulation ofthe dedicated touch screen icon causes bedside system to advance thepercutaneous device in accordance with an associated axial step movementprofile or rotation movement profile.

In one embodiment, bedside system 12 may be equipped with a steerableguide catheter 64 that may be steered by bending the distal tip via bendactuator 82 in response to a user's manipulation of controls 16. In thisembodiment, the distal tip of steerable guide catheter 64 may be bent toa particular shape or angle to position guide catheter 64 properly toperform a particular procedure, and movement instruction module 114 mayinclude one or more instruction sets that define a movement profileconfigured to cause bedside system 12 to move the distal tip of guidecatheter 64 to the desired position. In one embodiment, procedurecontrol module 98 may be configured to display several icons (such asicons 162, 164, or 166) on touch screen 18 each indicating a differentbend angle or bend shape (e.g., a button for a 30 degree bend, a buttonfor a 40 degree bend, a button for the Judkins Left 4 bend, a button forthe Judkins Right 4 bend, etc.), and when the user pushes the button fora particular degree bend or bend shape, the instruction set of movementinstruction module 114 associated with the selected icon is executedcausing the distal tip of guide catheter 64 to move to the bend angle orbend shape associated with the selected icon.

In another embodiment, movement instruction module 114 may include setsof instructions specific to various types of catheter based proceduresthat may be performed using bedside system 12. For example, movementinstruction module 114 may include one set of instructions that will beexecuted if bedside system 12 is being used to perform a diagnosticcatheterization procedure, shown as diagnostic procedure instruction set186, and another set of instructions that will be executed if bedsidesystem 12 is being used to perform a therapeutic catheter procedure,shown as therapeutic procedure instruction set 188. In this embodiment,controls 16 may include at least one user input device (e.g., touchscreen icons 162, 164, 166) that allows the user to select whethercatheter procedure system 10 is going to be used for a diagnostic ortherapeutic procedure. In this embodiment, a user input device (e.g.,touch screen icon 162, 164, 166) of controls 16 may be associated with adiagnostic procedure and another user input device may be associatedwith a therapeutic procedure, and selection or operation of theassociated user input device by the user activates diagnostic procedureinstruction set 186 or therapeutic procedure instruction set 188.

In addition, diagnostic procedure instruction set 186 or therapeuticprocedure instruction set 188 may include various subsets ofinstructions for various types of diagnostic or therapeutic proceduresthat may be performed using bedside system 12. In one such embodiment, auser input device (e.g., touch screen icon 162, 164, 166) of controls 16may be associated with a specific type of therapeutic procedure, andselection or operation of the associated user input device activates theappropriate instruction set of therapeutic procedure instruction set 188that is related to the specific type of therapeutic procedure to beperformed. For example, therapeutic procedure instruction set 188 mayinclude a first instruction set associated with a stent placementprocedure, a second instruction set associated with an angioplastyprocedure, a third instruction set associated with an ablationprocedure, etc. Thus, in this embodiment, the user will select the typeof therapeutic procedure that is to be performed via the associated userinput device, and the instruction subset of therapeutic procedureinstruction set 188 for the selected type of therapeutic procedure willbe activated.

In other embodiments, movement instruction module 114 may include setsof instructions specific to various types of percutaneous devices thatmay be used with bedside system 12, shown as device specific instructionsets 190. For example, device specific instruction sets 190 may includea set of instructions for each different type, make and/or model ofpercutaneous devices that may be used with bedside system 12. In such anembodiment, the instruction set for a particular type, make or model ofpercutaneous device may account for the properties of the device (e.g.,weight, diameter, surface friction, rigidity, etc.) to ensure that thepercutaneous device is moved as expected by bedside system 12. Inaddition, the instruction set for a particular percutaneous device maybe based on the type of device being controlled by bedside system 12(e.g., a guide wire, guide catheter, a working catheter, an angioplastyballoon, a stent, ablation catheter, imaging catheter, etc.).

Some percutaneous devices are designed to be moved or controlled in aparticular way during treatment of a condition. Device specificinstruction sets 190 may include one or more instruction sets to causebedside system 12 to move such a percutaneous devices in a mannerconsistent with its design. For example, in one embodiment, devicespecific instruction sets 190 may include one or more instruction setsto allow bedside system 12 to control a device specially designed totraverse a chronic total occlusion (e.g., the CrossBoss CTO Cathetermanufactured by BridgePoint Medical). In this embodiment, movementinstruction module 114 includes an instruction set that allows bedsidesystem 12 to rotate the CrossBoss CTO Catheter at its specified speed.

In another exemplary embodiment, device specific instruction sets 190may include one or more instruction sets to allow bedside system 12 tocontrol the Symplicity Catheter manufactured by Ardian, Inc. for thetreatment of hypertension. The Symplicity Catheter emits low-powerradiofrequency energy to deactivate certain renal nerves from within therenal artery to treat hypertension. In this embodiment, movementinstruction module 114 includes an instruction set to cause theSymplicity Catheter to retract a certain distance, to rotate a certainamount, and to emit a pulse of radiofrequency energy following rotationand retraction. In this embodiment the retract distance and the rotationamount are determined to position the Symplicity Catheter in the properlocations to deactivate the proper number of renal nerves to treathypertension.

Controller 40 also includes simulation module or subsystem 100, assistmodule or subsystem 102, mode selection module or subsystem 104,inventory module or subsystem 106, GUI module or subsystem 108, datastorage module or subsystem 110, and record module or subsystem 112.Generally, simulation module 100 is configured to run a simulatedcatheterization procedure based upon stored vascular image data and alsobased upon a user's manipulation of controls 16. Generally, assistmodule 102 is configured to provide information to the user located atworkstation 14 during a real and/or simulated catheterization procedureto assist the user with the performance of the procedure. Specificembodiments of controller 40, including specific embodiments ofsimulation module 100, and assist module 102, are described in detail inP.C.T. International Application No. PCT/US2009/055318, filed Aug. 28,2009, which is incorporated herein by reference in its entirety. Otherspecific embodiments of controller 40, including specific embodiments ofGUI module 108, are described in P.C.T. International Application No.PCT/US2009/055320, filed Aug. 28, 2009, which is incorporated herein byreference in its entirety.

Movement instruction module 114 has been described as including variousinstructions sets in various exemplary embodiments as discussed above.However, it should be understood that movement instruction module 114may include any combination of one or more of the instruction setsdiscussed above. In any embodiment in which movement instruction module114 includes more than one instruction set, controller 40 may beconfigured to select one or more proper instruction set to be activatedfor a particular procedure either automatically or based on a receiveduser input.

In various embodiments, controller 40 may be configured to allow theuser of controls 16 to choose which instruction set or sets of movementinstruction module 114 to activate for a particular procedure. In onesuch embodiment, one or more user input device (e.g., touch screen icon162, 164, 166, a button, switch, etc.) of controls 16 may be associatedwith a particular movement instruction set, and selection or operationof the associated user input device activates the instruction set ofmovement instruction module 114 related to the desired movementparameter or movement profile. Then, with one of the instruction setsactivated via operation of the associated user input device, thepercutaneous device is moved in accordance with the activated movementinstruction set as the user manipulates controls 16 (e.g., a joystick).

In one embodiment, procedure control module 98 may display informationassociated with one or more of the available instruction sets ofmovement instruction module 114 from which the user may chose. Forexample, a list of available instruction sets (e.g., instruction set forpulsed axial movement, instruction set for corkscrew motion, instructionsets for different percutaneous devices, etc.) may be displayed on adisplay device. In this embodiment, the user may then select the desiredinstruction set from the list to activate that instruction set using adevice such as a mouse or touch screen. When an instruction set ofmovement instruction module 114 is activated, control signal 116 and theresulting movement of percutaneous device is based upon the user'smanipulation of controls 16 and based upon the activated instructionset. In one embodiment, controller 40 is configured to display aseparate touch screen icon associated with each movement instruction setof movement instruction module 114. In another embodiment, eachavailable instruction set may be displayed as a list (e.g., a drop-downmenu) allowing the user to select the desired instruction set via aninput device such as a mouse.

In other embodiments, controller 40 may be configured such that one ormore movement instruction set of movement instruction module 114 may beactive at one time. In this embodiment, the user may activate anycombination of one or more instruction sets of movement instructionmodule 114 via the associated user input devices. In one embodiment, theuser may select more than one instruction set from the list of availableinstruction sets. For example, the user may activate both the axial stepmovement profile and the rotational movement profile at the same time,such that operation of controls 16 causes bedside system 12 to move thepercutaneous device both for rotation and pulsed axial advancement. Asanother example, the user may select one instruction set of the devicespecific instruction sets 190 for the device that the user iscontrolling via bedside system 12 and may select another instruction setfor the type of movement (e.g., pulsed movement, corkscrew movement,etc.). In another embodiment, the user may also select an additionalinstruction set associated with the type of procedure being performed(e.g., diagnostic, therapeutic, etc.). In other embodiments, a subset ofthe available movement instruction sets of movement instruction module114 may be selectable by the user (e.g., profiles 182 and 184), andanother subset of the available movement instruction sets of movementinstruction module 114 may be automatically selected by controller 40,as described in more detail below. Once one or more instruction sets ofmovement instruction module 114 are activated, bedside system 12 will beoperated based upon the user's manipulation of controls 16 and basedupon the one or more activated instruction set.

In some embodiments, procedure control module 98 may be configured toautomatically select or activate one or more of the availableinstruction sets of movement instruction module 114 based upon dataavailable to or received by controller 40. In one embodiment, theinstruction set that is automatically activated is associated with afeature of the percutaneous device being controlled. In variousembodiments, the feature of the percutaneous device may include thetype, make, model and a physical property of the percutaneous device. Inone such embodiment, the user may indicate the type of percutaneousdevice being used for a procedure, and procedure control module 98 mayautomatically activate the instruction set associated with thatparticular type of percutaneous device. The user may indicate the typeof percutaneous device by any suitable means, for example, entry of thename, model number, or other identifying information of the percutaneousdevice via a keyboard, selection of the particular percutaneous devicefrom a list, scanning of a barcode associated with the percutaneousdevice with a barcode reader in communication with controller 40, etc.In another embodiment, catheter procedure system 10 may include an RFIDreader that reads an RFID tag containing identifying informationassociated with a percutaneous device that has been loaded into bedsidesystem 12. The identifying information or data read by the RFID readermay then be communicated to procedure control module 98, and procedurecontrol module 98 may select the appropriate instruction set frommovement instruction module 114 based on the identifying informationread by the RFID reader.

In one embodiment, assist module 102 may be configured to provideinformation to the user (e.g., via display on monitor 26 and/or 28,etc.) to aid in the selection of the proper instruction set of movementinstruction module 114 for a particular procedure. In one embodiment,assist module 102 may display a suggestion to the user regarding whichinstruction set should be activated for a particular procedure. In oneembodiment, the suggestion generated by assist module 102 may be basedon analysis of image data of a patient acquired during a diagnostic ortherapeutic procedure. In one embodiment, assist module 102 may beconfigured to assess one or more property (e.g., density, degree ofcalcification, etc.) of a lesion (e.g., an atherosclerosis, etc.), andmay suggest a movement instruction set suitable for traversing thelesion with the percutaneous device. For example, if a particular lesionis identified to have a high degree of calcification, assist module 102may select a movement instruction set suitable to allow the percutaneousdevice to traverse the lesion, such as a pulsed movement instruction setwith a relatively low pulse duration may.

As mentioned, catheter procedure system 10 may be used to performcatheter based medical procedures. Typically, catheter based medicalprocedures involve the placement of a guide wire at a desired locationin a patient's arterial system (e.g., the distal end of the guide wirepositioned at or past a target lesion). Controller 40 may be used tooperate bedside system 12 to advance a guide wire through a patient'sarterial system until the distal end of the guide wire is positioned atthe desired location. FIG. 6 illustrates a method for navigating a guidewire in accordance with an embodiment. At block 302, the guide wirenavigation process is begun. In an exemplary procedure, the guide wiremay be inserted into an incision in the patient and, for example, intothe femoral artery. At block 304, bedside system 12 is operated toadvance the guide wire through the arterial system. In one embodiment, auser operates the bedside system 12 by manipulation of controls 16. Forexample, controller 40 generates control signals based upon the userinput and controls the bedside system 12 (e.g., the guide wireadvance/retract actuator 72) to advance the guide wire along a paththrough the coronary anatomy. The path may be traversed in discretelength steps based on the input provided by the user. In anotherembodiment, the user may provide a set of parameters that define apredetermined path to, for example, a target lesion. In this embodiment,controller 40 is configured to automatically advance the guide wirealong the predetermined path. For example, the movement instructionmodule 114 of controller 40 may include a guide wire navigation module192 (shown in FIG. 5) that is configured to control the bedside system12 to advance the guide wire along the predetermined path.

At block 306, it is determined whether the guide wire is advancingthrough the proper path. FIG. 7A illustrates an exemplary path to alesion in the heart. In FIG. 7A, a guide wire 402 is passed through aguide catheter 404 into an artery 412 of the heart 406. A path to atarget lesion 408 may, for example, pass though one or more junctionpoints 414 in the coronary anatomy. The guide wire 402, in particular adistal end 410 of the guide wire 402, needs to be advanced through theproper vessels to reach the desired location, for example, the targetlesion 408. In one embodiment, an imaging system 32 may be used toprovide fluoroscopic images of a region of interest showing the path tothe target lesion. The images may be displayed (for example, on amonitor 26, 28) and used to determine if the guide wire is passingthrough the correct passageway (or vessel) to reach the desiredlocation. In one embodiment, a user may view the images on a display todetermine the location of the guide wire. In another embodiment,controller 40 may be configured to process the images to determine thelocation of the guide wire.

Returning to FIG. 6, if the guide wire is not advancing along thecorrect path (e.g., the guide wire does not track into the correctvessel or branch at a junction point), the user may provide an input tooperate the bedside system 12 to retract the guide wire. In anotherembodiment, the controller 40 may be configured to automatically retractthe guide wire when it is determined that the guide wire is notadvancing along the correct path. In this embodiment, the guide wirenavigation module 192 may be configured to automatically retract theguide wire. At block 308, the controller 40 (for example, the guide wirenavigation module 192) is configured to control the bedside system 12 torotate and retract the guide wire in response to a control signal toretract the guide wire. In one embodiment, the guide wire is rotated andthen retracted. In another embodiment, the guide wire may be retractedand then rotated. In yet another embodiment, the guide wire is rotatedand retracted simultaneously. Accordingly, the guide wire rotates whilebeing retracted. In one embodiment, the proximal end of the guide wireis rotated (e.g., using a guide wire rotate actuator) a predeterminedamount (e.g., 180 degrees). In another embodiment, the guide wire mayfirst be rotated a first amount in a first direction and then rotated asecond amount in the opposite direction. FIG. 7B shows a guide wire 402retracted to a point before the junction 414. In one embodiment, theguide wire 402 is retraced a distance that positions the distal end 410of the guide wire before the junction point 414. As mentioned, the guidewire is rotated while being retracted. In another embodiment, if it isrequired to retract the guide wire multiple times to position the distalend 410 prior to the junction 414, the guide wire may only be rotatedwith the first retraction of the guide wire.

At block 310 of FIG. 6, bedside system 12 is operated to advance theguide wire. FIG. 7C shows the guide wire 402 advanced past the junctionpoint 414 and into the desired path to the target lesion 408. In oneembodiment, a user operates the bedside system 12 by manipulation ofcontrols 16. In another embodiment, controller 40 (for example, guidewire navigation module 192) is configured to automatically advance theguide wire along a predetermined path. At block 306 of FIG. 6, if theguide wire is still not advancing along the correct path, steps 306 to310 are repeated until the guide wire is located in the correctpassageway. In one embodiment, the controller 40 (for example, guidewire navigation module 193) is configured to automatically repeat theiterations of steps 306 to 310 until a user provides an input indicatingthe guide wire is in the correct passageway. In one embodiment, theamount of rotation of the guide wire is changed for each retraction ofthe guide wire (i.e. with each iteration). At block 312, it isdetermined whether the guide wire is positioned at the desired location(e.g., at a target lesion). If the guide wire is not at the properlocation, the process returns to block 304 and the guide wire isadvanced. If the guide wire is at the desired location, the next stepsin the catheter procedure may begin at block 314. For example, a workingcatheter may be positioned and a therapeutic procedure performed.

Computer-executable instructions for navigating a guide wire accordingto the above-described method may be stored on a form of computerreadable media. Computer readable media includes volatile andnonvolatile, removable, and non-removable media implemented in anymethod or technology for storage of information such as computerreadable instructions, data structures, program modules or other data.Computer readable media includes, but is not limited to, random accessmemory (RAM), read-only memory (ROM), electrically erasable programmableROM (EEPROM), flash memory or other memory technology, compact disk ROM(CD-ROM), digital versatile disks (DVD) or other optical storage,magnetic cassettes, magnetic tape, magnetic disk storage or othermagnetic storage devices, or any other medium which can be used to storethe desired instructions and which may be accessed by system 10 (shownin FIG. 1), including by internet or other computer network form ofaccess.

Further modifications and alternative embodiments of various aspects ofthe invention will be apparent to those skilled in the art in view ofthis description. Accordingly, this description is to be construed asillustrative only. The construction and arrangements, shown in thevarious exemplary embodiments, are illustrative only. While the currentapplication recites particular combinations of features in the claimsappended hereto, various embodiments of the invention relate to anycombination of any of the features described herein whether or not suchcombination is currently claimed, and any such combination of featuresmay be claimed in this or future applications. Any of the features,elements, or components of any of the exemplary embodiments discussedabove may be used alone or in combination with any of the features,elements, or components of any of the other embodiments discussed above.Although only a few embodiments have been described in detail in thisdisclosure, many modifications are possible (e.g., variations in sizes,dimensions, structures, shapes and proportions of the various elements,values of parameters, mounting arrangements, use of materials, colors,orientations, etc.) without materially departing from the novelteachings and advantages of the subject matter described herein. Someelements shown as integrally formed may be constructed of multiple partsor elements, the position of elements may be reversed or otherwisevaried, and the nature or number of discrete elements or positions maybe altered or varied. The order or sequence of any process, logicalalgorithm, or method steps may be varied or re-sequenced according toalternative embodiments. Other substitutions, modifications, changes andomissions may also be made in the design, operating conditions andarrangement of the various exemplary embodiments without departing fromthe scope of the present invention.

What is claimed is:
 1. A method for navigating a guide wire during acatheter procedure, the method comprising: advancing a guide wirethrough a path using a catheter procedure system; determining if theguide wire is in a desired path based at least on at least one image ofa region of interest; rotating the guide wire using the catheterprocedure system if the guide wire is not in the desired path, whereinthe guide wire is rotated a predetermined amount; retracting the guidewire using the catheter procedure system; repeating the steps ofadvancing the guide wire and rotating and retracting the guide wireusing the catheter procedure system until the guide wire is in thedesired path; and advancing the guide wire to a desired position usingthe catheter procedure system.
 2. A method according to claim 1, whereinretracting the guide wire occurs while the guide wire is rotated.
 3. Amethod according to claim 1, wherein the guide wire is retracted apredetermined amount.
 4. A method according to claim 1, wherein the atleast one image is a fluoroscopic image.
 5. A method according to claim1, wherein the steps of advancing the guide wire and retracting androtating the guide wire are repeated until a user input is receivedindicating the guide wire is in the desired path.
 6. A method accordingto claim 1, wherein the guide wire is rotated and retracted in responseto a user input to retract the guide wire.
 7. A method for navigating aguide wire during a catheter procedure, the method comprising: receivinga set of parameters defining a predetermined path; automaticallyadvancing a guide wire through the predetermined path using a catheterprocedure system; determining if the guide wire is in the predeterminedpath based at least on at least one image of a region of interest;rotating the guide wire using the catheter procedure system if the guidewire is not in the predetermined path, wherein the guide wire is rotateda predetermined amount; retracting the guide wire using the catheterprocedure system; repeating the steps of advancing the guide wire andretracting and rotating the guide wire using the catheter proceduresystem until the guide wire is in the predetermined path; and advancingthe guide wire to a desired position using the catheter proceduresystem.
 8. A method according to claim 7, wherein retracting the guidewire occurs while the guide wire is rotated.
 9. A method according toclaim 7, wherein the guide wire is retracted a predetermined amount. 10.A method according to claim 7, wherein the at least one image is afluoroscopic image.
 11. A catheter procedure system comprising: abedside system comprising a guide wire, a guide wire advance/retractactuator coupled to the guide wire and a guide wire rotate actuatorcoupled to the guide wire; and a workstation coupled to the bedsidesystem, the workstation comprising: a user interface; at least onedisplay; a controller coupled to the bedside system, the user interfaceand the at least one display, the controller programmed to: advance theguide wire through a path using the guide wire advance/retract actuator;determine if the guide wire is in a desired path based at least on atleast one image of a region of interest; rotate the guide wire using theguide wire rotate actuator if the guide wire is not in the desired path,wherein the guide wire is rotated a predetermined amount; retract theguide wire using the guide wire advance/retract actuator; repeat thesteps of advancing the guide wire and retracting and rotating the guidewire using guide wire advance/retract actuator and the guide wire rotateactuator until the guide wire is in the desired path; and advance theguide wire to a desired position using the guide wire advance/retractactuator.
 12. A catheter procedure system according to claim 11, whereinretracting the guide wire occurs while the guide wire is rotated.
 13. Acatheter procedure system according to claim 11, wherein the at leastone image is a fluoroscopic image.
 14. A catheter procedure systemaccording to claim 11, wherein the steps of advancing the guide wire andretracting and rotating the guide wire are repeated until a user inputis received indicating the guide wire is in the desired path.
 15. Acatheter procedure system comprising: a bedside system comprising aguide wire, a guide wire advance/retract actuator coupled to the guidewire and a guide wire rotate actuator coupled to the guide wire; and aworkstation coupled to the bedside system, the workstation comprising: auser interface; at least one display; a controller coupled to thebedside system, the user interface and the at least one display, thecontroller programmed to: receive a set of parameters defining apredetermined path using the user interface; advance the guide wirethrough the predetermined path using the guide wire advance/retractactuator; determine if the guide wire is in the predetermined path basedat least on at least one image of a region of interest; rotate the guidewire using the guide wire rotate actuator if the guide wire is not inthe predetermined path, wherein the guide wire is rotated apredetermined amount; retract the guide wire using the guide wireadvance/retract actuator; repeat the steps of advancing the guide wireand simultaneously retracting and rotating the guide wire using theguide wire advance/retract actuator and the guide wire rotate actuatoruntil the guide wire is in the predetermined path; and advance the guidewire to a desired position using the guide wire advance/retractactuator.
 16. A catheter procedure system according to claim 15, whereinretracting the guide wire occurs while the guide wire is rotated.
 17. Acatheter procedure system according to claim 15, wherein the at leastone image is a fluoroscopic image.